Export of Drugs & Pharmaceuticals covered under the provisions of Drugs & Cosmetics Act 1940 - DGFT - 173 (RE-2008) /2004-2009

Superseded vide Public Notice No. 21 (RE-2011)/2009-2014, dated 10/01/2011 Export of Drugs Pharmaceuticals covered under the provisions of Drugs Cosmetics Act 1940 TO BE PUBLISHED IN THE GAZETTE OF INDIA EXTRAORDINARY (PART-I, SECTION-I) GOVERNMENT OF INDIA MINISTRY OF COMMERCE AND INDUSTRY DEPARTMENT OF COMMERCE DIRECTORATE GENERAL OF FOREIGN TRADE PUBLIC NOTICE NO. 173 (RE-2008) /2004-2009 NEW DELHI, DATED THE 13TH APRIL, 2009 In exercise of the powers conferred under Paragraph 2.4 of the Foreign Trade Policy, 2004-2009 , as amended from time to time, it has been decided to notify, with immediate effect, procedures/guidelines to strengthen the enforcement mechanism available under the Drugs and Cosmetics Act, 1940, to ensure that counterfeit drugs do not get exported out of the country. 1 [ 1.Every exporter of Drugs Pharmaceuticals at the time of shipment shall submit, alongwith other required documents, the following: (i) A copy of Certificate of Analysis issued by the manufacturer for the subject products; Or (ii) A copy of Certificate of Analysis issued by approved laboratory of the importing country/ FDA; Or (iii) A copy of Certificate of Analysis issued by a laboratory approved by Drugs Controller under Drugs Cosmetics Act, 1940 and the rules made thereunder. Where required the officials of the Drug Control Department posted at the port offices shall retain a sample of the subject consignment for the purpose of reference and tracking of the manufacturer/ exporter of the subject product. 3. Exporter of Pharmaceutical products will build track and trace capability for their exported medicines using barcode technology as per GS 1 global standards. The same will need to be done at primary, secondary and tertiary level packaging labels as per details below:- a. Primary Level packaging: Incorporation of 2D (GS 1 Data matrix) barcodes on medicines at strip/vial/bottle level encoding unique product identification code (GTIN), Batch Number, Expiry Date and Serial Number of the Primary pack. b. Secondary Level packaging Incorporation of barcodes (1D or 2 D) encoding unique product identification code (GTIN), Batch Number, Expiry Date and Serial Number of the Secondary pack. c. Tertiary Level packaging Incorporation of barcodes (1 D) encoding unique product identification code (GTIN), Batch Number, Expiry Date and Serial Number of the Tertiary pack (shipper/carton) 1. The trace and track technology as per Serial Number 3 above, will come into effect from 1st July, 2011. ] 2. Export of Drugs Pharmaceuticals covered under the provisions of Drugs Cosmetics Act 1940 and the rules made thereunder, which is being regulated by Drugs Controller General of India (DCGI) in the Ministry of Health Family Welfare, shall be as per the requirements given hereunder: Every exporter of Drugs Pharmaceuticals at the time of shipment shall submit, alongwith other required documents, the following: (i) A copy of Certificate of Analysis issued by the manufacturer for the subject product; Or (ii) A copy of Certificate of Analysis issued by approved laboratory of the importing country/FDA; Or (iii) A copy of Certificate of Analysis issued by a laboratory approved by Drugs Controller under Drugs Cosmetics Act 1940 and the rules made thereunder. Wherever required the officials of the Drug Control Department posted at the port offices shall retain a sample of the subject consignment for the purpose of reference and tracking of the manufacturer/exporter of the subject product. 3. This issues in Public Interest. (R.S. GUJRAL) DIRECOR GENERAL OF FOREIGN TRADE And Ex-Officio Additional Secretary to the Govt. of India (Issued from F.No.01/91/180/648/AM09/Export Cell) ------------------------------------------- Notes:- 1. Added vide Public Notice No. 21 (RE-2011)/2009-2014, dated 10/01/2011